Clinical trial

Management of Postsurgical Pain After Cardiac Operations: Comparison of Tapentadol and Tramadol Analgesia

Name

668/24.02.2020

Description

The aim of this randomized one-blinded study will be to evaluate the efficacy and tolerability of two different oral doses of tapentadol and compare it to tramadol (an opioid commonly used to treat post-surgical pain) in cardiac surgery patients

Trial arms

Trial start

2022-11-01

Estimated PCD

2024-12-31

Trial end

2024-12-31

Status

Recruiting

Treatment

Group tapentadol 50 mg

patients in group A will receive tapentadol 50 mg p.o 3 times daily for two days

Arms:

tapentadol 50 mg

Other names:

group A

group tapentadol 75 mg

patients in group B will receive tapentadol 75 mg p.o 3 times daily for two days

Arms:

tapentadol 75 mg

Other names:

group B

group tramadol 100 mg

patients in group C will receive tramadol 100 mg p.o 3 times daily for two days

Arms:

tramadol 100 mg

Other names:

group C

Size

Primary endpoint

change from baseline in pain score at rest

2 hours after analgesia administration

change from baseline in pain score during coughing

2 hours after analgesia administration

side effects

2 hours after analgesia administration

incidence of chronic pain 3 months after surgery

3 months after surgery

incidence of chronic pain 6 months after surgery

6 months after surgery

incidence of neuropathic pain 3 months after surgery

3 months after surgery

incidence of neuropathic pain 6 months after surgery

6 months after surgery

Eligibility criteria

Inclusion Criteria: * age \<75 years old * patients discharged from Intensive Care Unit (ICU) in less than 30 hours * elective cardiac surgery Exclusion Criteria: * hepatic failure (increased transaminase levels * renal failure (creatinine\> 2 mg/dL) * ileus * emergency surgery (hemorrhage, tamponade, aortic dissection) * readmission in ICU * treatment with monoaminoxidase inhibitors, selective serotonine reuptake inhibitors or antiepileptics * age\>75 years old * communication or language barriers * Lack of informed consent

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 90, 'type': 'ESTIMATED'}}

Updated at

2023-02-08

1 organization

2 products

9 indications

Organization

Aretaieion University Hospital

Product

Tapentadol

Indication

Postoperative Pain

Indication